In today’s strictly regulated pharmaceutical industry, the need for temperature monitoring solutions is paramount. The quality, reliability, and durability of these solutions can have a significant impact on product efficacy, safety, and compliance. SenseAnywhere is a leading engineering and manufacturing company specialising in next-gen temperature monitoring solutions, designed to tackle some of the key industry challenges and optimise pharmaceutical supply chains. This white paper will delve into the essential features and capabilities of SenseAnywhere’s temperature monitoring products, which are crucial for ensuring quality, efficiency, security, and sustainability in logistics, regulatory compliance, cost management, and time management for successful pharma businesses.
Global Leader in Cloud-based Monitoring & Data-Logging Technology
SenseAnywhere’s early adoption of Cloud-based technology brings numerous benefits to pharmaceutical companies worldwide. The system is efficient, quick, and easy to deploy on a plug-and-play basis. The impressive 10-year lifespan of the AiroSensor data logger battery provides a unique advantage for businesses, allowing for a cost-effective long-term strategy without compromising on quality and security.
SenseAnywhere’s Cloud-based technology has a long-standing trusted presence in more than 80 countries around the world, setting the benchmark for excellence in the industry and ascertaining the company’s position as a global leader for Cloud-based monitoring systems.
Revolutionary ‘Set & Forget’ System
SenseAnywhere understands the critical importance of temperature monitoring in safeguarding the integrity of pharmaceutical products, including temperature-sensitive drugs, biologicals, vaccines, and other injectables. The company’s innovative ‘Set & Forget’ system empowers team members to set up the AiroSensor data loggers easily, leaving them to operate autonomously, reassured with the knowledge that measurements are recorded every 5 minutes, 24/7. In the event of any deviation from the optimal temperature range, the system generates instant email/SMS or voice alerts, providing the team additional time to intervene and protect the company’s valuable stock. With SenseAnywhere’s technology at their disposal, coordinators and supply chain managers can have full confidence in the safety and security of the company’s pharmaceutical inventory, ensuring compliance with regulatory requirements and maintaining the highest standards of quality control. The ground-breaking ‘Set & Forget’ System delivers unmatched peace of mind to pharmaceutical business managers, ensuring seamless and reliable temperature monitoring for your product integrity and critical compliance operations.
Focus on Security and Reliability
SenseAnywhere prioritises the security and reliability of their solutions. Data is safely and securely stored with Microsoft Azure, a leading Cloud infrastructure platform. The data is encrypted, stored in real-time, and backed up every five minutes. Azure leads the industry with the most comprehensive compliance coverage, enabling customers to meet a wide range of regulatory obligations. The High Availability architecture in Azure guarantees that our database is up and running 99.99% of the time without worrying about the impact of maintenance operations and outages.
The SenseAnywhere Software is developed according to the GAMP5 rules, a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry. All the hardware, firmware, and software in SenseAnywhere products have been developed in-house by their own software team and are owned by SenseAnywhere. Communication of the data loggers, as well as the portal, undergoes regular penetration (PEN) testing. These measures ensure that SenseAnywhere products are ultra-secure and reliable. In addition, SenseAnywhere complies with the requirements of FDA 21 CFR part 11.
SenseAnywhere Monitoring System is Validated
The SenseAnywhere Monitoring System is extensively validated. Every facet of the English Enterprise version of SenseAnywhere’s SAClient Portal is thoroughly tested. All tests and test results are documented in detail in SenseAnywhere’s Manufacturer Software Validation (MSV) documents. To assist customers with GxP requirements for SenseAnywhere products, SenseAnywhere provides validation documents, including the Manufacturer Software Validation (MSV) and MSV Addendums, Installation Qualification (IQ) and Operational Qualification (OQ) Documentation set, and a Design Qualification (DQ). These validation documents ensure that SenseAnywhere products comply with regulatory requirements, giving customers the assurance, they need.
SenseAnywhere has obtained several certifications and approvals, demonstrating its commitment to quality and security. The company has achieved ISO 9001:2015 certification, which specifies the requirements for a quality management system, ensuring that SenseAnywhere products and services meet customer and regulatory requirements. Additionally, the ISO 27001:2013 certificate provides independent assurance that SenseAnywhere has a robust, systematic, and risk-based approach to information security. The ISO 14001:2015 certificate demonstrates SenseAnywhere’s commitment to reducing its environmental impact in the production of temperature monitoring devices.
The Calibration Laboratory at SenseAnywhere has achieved ISO/IEC 17025 accreditation, which ensures that every sensor is meticulously tested and calibrated in their Calibration Lab before shipment. The accreditation for the laboratory management system highlights SenseAnywhere’s commitment to quality, competency, and reliable results. Furthermore, the ISO/IEC 17025 accreditation is a globally recognized standard that enables the exchange of valuable data and information across international borders.
SenseAnywhere’s temperature data loggers meet the most stringent class of the EU regulation for data loggers EN12830:2018 with 0.1°C highest accuracy class, providing customers with accurate and reliable temperature monitoring. SenseAnywhere hardware is also FCC, IC, and CE tested for compliance, ensuring that the company’s products meet the highest safety and performance standards.
Orange is the New Green
SenseAnywhere is committed to sustainability and reducing its environmental impact. The company’s products are engineered and manufactured with sustainability in mind, reducing chemical, plastic, and paper waste. The AiroSensor data loggers have a battery life of 10 years, reducing the carbon footprint involved in the production and disposal of batteries in loggers with a shorter shelf life. The AiroSensors are designed to have small dimensions, reducing the use of production resources and minimising plastic, electronic, and chemical waste.
SenseAnywhere implements its eco-friendly approach in all areas of its business. The company uses minimal, plain, carton packaging to prevent waste and minimal paper documentation, providing digital manuals and certificates. SenseAnywhere’s products function paperless, and all SenseAnywhere measurements are stored in the digital Cloud environment, providing a safe and green alternative to paper.
SenseAnywhere’s office buildings are powered by solar panels, reducing the emission of CO2 into the environment. The company has also installed LED lights throughout its office spaces, reducing energy use, and has an Energy label A – the most economical use possible. SenseAnywhere separates waste for recycling, and many of the company’s employees travel to work by bicycle, reducing the company’s CO2 footprint even further. SenseAnywhere is continuously exploring new and innovative ways to dispose of and recycle its end-of-life products for a greener and brighter future.
Simply Smarter Cloud-based Monitoring
The SenseAnywhere Cloud-based monitoring system has proven to be highly effective across various applications and industries and is particularly well suited to benefit companies operating in the pharmaceutical sector. SenseAnywhere has established a wide network of distributors globally, and its products are sold worldwide with excellent support provided in the local language. Please speak to your local representative about the long list of benefits this fully compliant system can present and ask them to share the countless testimonials from SenseAnywhere’s satisfied pharmaceutical industry customers.
Visit https://www.senseanywhere.com/resellers and get in contact with one of SenseAnywhere’s local distributors today.